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Inventories
12 Months Ended
Dec. 31, 2015
Inventory Disclosure [Abstract]  
Inventories

3) Inventories

 

The Company uses the lower of first-in, first-out (“FIFO”) cost or market method of accounting for inventory. 

 

Inventories consist of the following:   (in thousands)  
    2015     2014  
Inventory work-in-process, January 1   $     $  
Production     1,443        
Spoilage     (117 )      
Inventory work-in-process, December 31   $ 1,326     $  

 

Commercial sales of Alferon® will not resume until new batches of commercial filled and finished product are produced and released by the FDA. The Company is continuing the validation of Alferon® production and production of new Alferon® API inventory commenced in February 2015. While the facility is approved by the FDA under the Biological License Application (“BLA”) for Alferon®, this status will need to be reaffirmed by an FDA pre-approval inspection. The Company will also need the FDA’s approval to release commercial product once it has submitted satisfactory stability and quality release data.